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Class I · Most seriousActive recall

Magnesium Sulfate

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot: AH250162, Exp 8/31/2027
Where it was soldU.S.A. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Brand nameMAGNESIUM SULFATE
Generic nameMAGNESIUM SULFATE IN WATER FOR
Active ingredient(s)MAGNESIUM SULFATE HEPTAHYDRATE
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC70121-1720-3
Show the full FDA record
Full product labelMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Recalling firmAmneal Pharmaceuticals, LLC
DistributionU.S.A. Nationwide
Quantity784 (12x100mL) cartons
Recall initiated2026-03-18
Report date2026-04-08
Recall completed—
Recall numberD-0478-2026
ClassificationClass I
FDA statusOngoing
Origin on fileBridgewater NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.